VTE Prevention With Rivaroxaban in Genitourinary Cancer Patients Receiving Systemic Therapy

• Status: Not yet recruiting
• Trial end date: 2026-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with genitourinary cancers (ex: bladder, testicular, kidney) are at high risk of developing blood clots if they receive systemic therapy (ex: chemotherapy, immunotherapy). Blood clots cause pain, may require hospitalization and invasive testing, and in some cases cause death. In fact, blood clots are one of the leading causes of death in patients with cancer. Furthermore, patients who develop a blood clot require medication to thin the blood for a prolonged (sometimes indefinite) period of time, and this can disrupt other important cancer treatments. Studies have shown that using low dose blood thinners to prevent blood clots during systemic therapy is effective in some patients with cancer. However very few patients in these studies had genitourinary cancers, therefore physicians in Canada are not sure if recommending blood thinners to patients with genitourinary cancers is useful or safe. Safety is a primary concern because blood thinners may cause bleeding, and patients with genitourinary cancers may have higher risk of bleeding than patients with other types of cancer. The investigators hypothesize that blood thinners are effective and safe for reducing blood clots in patients with genitourinary cancers. The objective of this study is to determine if a large clinical trial testing the effectiveness and safety of low dose blood thinners for preventing blood clots in patients with genitourinary cancers receiving systemic therapy is feasible.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR); Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network; Kidney Cancer Research Network of Canada
• Treatments: Rivaroxaban

Criteria

Inclusion Criteria:

• Patients who are starting systemic therapy for active GU cancer (bladder, testis, ureter/renal pelvis, kidney, urethral, penile) except for prostate cancer.

• Age ≥ 18

• Eligible systemic therapies include chemotherapy, targeted therapies (tyrosine kinase inhibitors and antiangiogenic therapy), and immunotherapies.

• Patients must be initiating systemic therapy with a minimum planned treatment duration of 8 weeks.

Exclusion Criteria:

• Anticoagulation (prophylactic or therapeutic dosing) required for another indication for entire duration of study

• Known allergies to rivaroxaban

• Concomitant use of dual antiplatelet therapy (two antiplatelet medications oncomitantly)

• Ongoing refractory bleeding that may be exacerbated by rivaroxaban.

• Concomitant use of strong inducers or inhibitors of CYP3A4 or glycoprotein-P (known interaction with rivaroxaban).

• Severe renal insufficiency (Creatinine clearance <30 mL/min (defined by Cockcroft-Gault))

• Severe liver disease (e.g. acute clinical hepatitis, chronic active hepatitis, cirrhosis)

• Thrombocytopenia < 50 x 109/L

• Life expectancy under 6 months.

• Pregnancy (if child bearing age under 50 and sexually active, documentation of use of effective contraception or negative B- HCG is required)

• Patient is breastfeeding or lactating

• History of condition at increased bleeding risk including, but not limited to:

cerebral infarction (hemorrhagic or ischemic), active peptic ulcer disease with recent bleeding, spontaneous or acquired impairment of hemostasis in the previous 4 weeks.

• Chronic hemorrhagic disorder

• Inability to adhere to protocol or obtain consent.

• Patients may be excluded from the study for other reasons, at the investigator's discretion.